The American Hospital Association and several other hospital groups are asking a federal court to order the Department of Health and Human Services to implement, within 30 days, a final rule requiring drug companies to disclose the ceiling price for 340B outpatient drugs. Read More
Proqr Therapeutics NV, of Leiden, the Netherlands, said it closed its underwritten public offering of 6.61 million ordinary shares at $15.75 each. Gross proceeds from the offering totaled approximately $104.1 million. Read More
Alivio Therapeutics Inc., a Boston-based affiliate of Puretech Health plc, secured a $3.3 million Department of Defense Technology/Therapeutic Development Award to advance ALV-107 for the treatment of interstitial cystitis/bladder pain syndrome with Hunner's lesions. Read More
Shares of Vital Therapies Inc. plunged 93 percent Wednesday after the San Diego-based firm reported another phase III miss with its ELAD cell-based therapy in acute forms of liver failure. Despite showing a numerical improvement in survival, the study, dubbed VTL-308, fell short of the primary endpoint seeking an improvement in overall survival in patients with severe alcoholic hepatitis through at least 91 days, as assessed using the Kaplan Meier statistical method. Read More
HONG KONG – Shanghai-based Fosun Kite Biotechnology Co. Ltd. was granted approval from China's National Medical Products Administration (NMPA) to advance its gene therapy candidate, FKC-876, to clinical trials. Read More
HONG KONG – Amid renewed interest in CD47 as an immuno-oncology target, Innovent Biologics Inc., of Suzhou, China, has received IND approval in China to start clinical trials of its monoclonal antibody (MAb), IBI-188. To further get ahead in the anti-CD47 race, Innovent will conduct clinical trials on IBI-188 at home and abroad simultaneously. Read More
LONDON – Half of all clinical trial sponsors in Europe have not complied with the requirement that results must be reported within 12 months of the study completing, according to research by transparency campaigner Ben Goldacre appearing Thursday in the British Medical Journal. Read More
With "so many things going on in our biotechnology industry," Mike Narachi said he had his pick of opportunities following the shutdown of Orexigen Therapeutics Inc., whose obesity drug, Contrave (naltrexone HCl/bupropion HCl), went to Pernix Therapeutics Holdings Inc. at the end of July following bankruptcy proceedings. Read More
A new strategic collaboration between Gilead Sciences Inc. and privately held Precision Biosciences Inc. will focus on developing therapies targeting the in vivo elimination of hepatitis B virus (HBV) with Precision's Arcus genome editing technology. Precision is eligible for milestone payments of up to $445 million under the terms of the deal and, if successful, could see tiered royalties on sales reaching the midteens. The agreement could eventually lead Gilead to a potent new offering in HBV, where generic medicines have decimated the once-formidable revenues generated by Viread (tenofovir disoproxil fumarate), and sales of its newer medicine, Vemlidy (tenofovir alafenamide), have yet to gain the same traction. Read More
DUBLIN – Shareholders in Galapagos NV enjoyed an 18 percent stock uptick Wednesday as filgotinib, the company's blockbuster-in-waiting, aced the first of three phase III trials in rheumatoid arthritis (RA) and whetted appetites for further phase III read-outs over the next nine months. Its partner, Gilead Sciences Inc., of Foster City, Calif., also traded up, by about 3 percent. That represents a combined valuation increase of about $3.5 billion across the two companies. Read More
